Associate Director, IT Quality Management, Hosting Network Cyber UX

Company: Celgene
Location: Princeton, New Jersey, United States
Type: Full-time
Posted: 03.MAY.2021

Summary

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunol...

Description

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.Position Summary:Lead and oversee IT Infrastructure Qualification efforts for infrastructure-related IT systems including infrastructure applications and toolsets used at Bristol-Myers Squibb (BMS). Lead a team of Subject Matter Experts (SMEs) for qualification of applications, infrastructure resources (i.e., servers, databases, storage) and server rooms in accordance with BMS' Solution Life Cycle (SLC), Infrastructure Life Cycle and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising on quality matters, and assisting with closing compliance gaps related to audits and inspections.Job Description:Lead and oversee IT infrastructure qualification efforts for systems used across multiple organizations focusing on IT infrastructure delivery. Build and execute quality practices into enterprise-wide IT infrastructure platforms, applications, tools, services, and components through the end-to-end lifecycle (plan, provision, operation, maintenance, retirement and decommission). Supervise workforce assigned to IT infrastructure projects ensuring efficiency, consistency, quality of work and compliance with external regulations and internal procedures. Collaborate with infrastructure hosting, network, cybersecurity and user experience teams and internal Global Quality compliance staff to ensure that IT infrastructure qualification activities are planned and executed in accordance with internal procedures. Work with one-up manager and peers to propose effective and efficient quality strategies for automation, where feasible. Refine and standardize SLC and infrastructure qualification processes for continuous improvement. Evaluate, propose, and implement technology solutions that improve digitization, compliance and productivity. Serve as a thought leader in support of internal and external regulatory inspections. Serve as a relationship lead with external service providers that deploy, qualify, and maintain IT infrastructure on behalf of the company.ResponsibilitiesOversees & executes qualification and Quality Management (QM) activities for IT infrastructure capabilities to ensure 'fit for use' before release to production environment.Collaborates and works closely with teams involved in Infrastructure Lifecycle Services such as Hosting Operations, Cloud Hosting/Engineering, Data Center/Server Room Operations, Network Services, Virtual Operations, Storage, Disaster Recovery, Backup & Recovery, and Cybersecurity.Participates and influences decision making in Steering Committees, Advisory Boards, Change Advisory Boards, Communities of Practice, and other relevant forums.Ensures that infrastructure and systems in-scope are remediated and maintained in a qualified state across all segments and regions globally.Ensures adherence to IT infrastructure qualification standards/SOPs/WIs.Identifies opportunities for simplification and partners with delivery teams to implement.Ensures inspection readiness in support of health authority inspections, audits (internal and external, and periodic review of infrastructure.Implementation of IT controls in accordance with applicable regulations and the ability to evaluate and understand the impact of new regulations and requirements.QM representative for IT infrastructure in problem management and audit remediation activities.Skills & Requirements:B.S. or equivalent in computer science, engineering, life science or related field. 8+ years' experience in IT infrastructure qualification / computer systems validation in the pharmaceutical industry (development of Qualification/CSV deliverables, review of infrastructure / software testing and verification, including at least 4+ years managing/overseeing Infrastructure Qualification / CSV projects.Candidate must be a subject matter expert in IT quality management, infrastructure qualification / computer system validation, GAMP, Electronic Records/Electronic Signature regulations, data integrity concepts and related health authority regulations and guidelines.Thorough knowledge of GAMP 5 regulations related to infrastructure control & compliance and CSV is requiredThorough knowledge of other Global Regulations like EU Annex 11, SOX, Security & Privacy, ISO is preferredKnowledge of the current and emerging technologies and methodologies highly desirable. For example, Server/EC2, Database/RDS, Storage, VMware, Agile, RPA, Cloud Storage and Computing, Intelligent Automation, Blockchain, and Kubernetes.Working knowledge of ITIL frameworks is highly desirableKnowledge of SLC Quality Management process and Computerized System Validation principlesKnowledge of the current and emerging technologies and methodologies highly desirable. For example, Server/EC2, Database/RDS, Storage, VMware, Agile, RPA, Cloud Storage and Computing, Intelligent Automation, Blockchain, and Kubernetes.Understands and provides inputs into operating plan and manages spend per plan.Demonstrated ability to manage people.Demonstrated ability to plan and organize effectively across multiple projects and tasks.Demonstrated ability to influence, collaborate, and communicate directlyAround the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

 
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